NCT05295030

Effects of Breast Milk Simulated Infant Formula

Completed NA Last updated 27 December 2024

What this trial tests

NA trial testing Breast milk in Infant Formula in 179 participants. Completed in 25 December 2023.

Timeline

10 April 2022

Primary endpoint
25 December 2023

25 December 2023

Quick facts

Lead sponsor	Sun Yat-sen University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	179
Start date	10 April 2022
Primary completion	25 December 2023
Estimated completion	25 December 2023
Sites	1 location across China

Drugs / interventions tested

• Breast milk — full drug profile →
• Kieember Infant formula, Ruibuen®
• Yashili Infant formula, Ruibuen®

Conditions studied

• Infant Formula — all drugs for Infant Formula →
• Breast Milk — all drugs for Breast Milk →

Sponsor

Sun Yat-sen University

Who can join

Adults 0 Days to 30 Days, any sex, with Infant Formula or Breast Milk. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Objective：The aim of this trial is to assess effects of Kieember and Yashili infant formula on body growth, behavior development, intestinal comfort, infectious diseases, allergic diseases, the absorption of nutrients and gut microbiota as compared to breast-milk in term infants aged 0-3 months.

Participants：144 healthy term infants aged less than 30 days at entry to study. Study Design: A open-label,parallel, controlled trial.

Arms, Groups, and Intervention: (1) Breast milk-fed group: fed with human breast milk; (2) Breast Milk Simulated Formula Group：fed with breast milk simulated infant formula (Ruibuen®Kieember, Phase I); (3) Traditional Formula Group: fed with traditional infant formula (Ruibuen®Yashili, Phase I).

Intervention Duration: 90 days.

Visits: 1month and 3month old.

Outcome measures: (1)Biochemical detection of feces (total fat, fatty acids, calcium, nitrogen);(2)Stool characteristics (frequency, color, volume, and stool consistency);(3)Anthropometric parameters (body length, body weight, and head circumferences);(4)Temperament and adaptive behavior;(5)Gut microbiota;(6)General health and wellbeing;(7)concomitant medications and adverse events.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. A Novel Infant Formula with Medium- and Long-Chain Triacylglycerols and <i>sn</i>-2 Palmitate Supports Adequate Growth and Lipid Absorption in Healthy Term Infants.
   Chen X, Yang M, Wei W, Huang S, et al · · 2025 · cited 4× · PMID 40362710 · DOI 10.3390/nu17091401
2. Impact of medium- and long-chain triacylglycerols and <i>sn</i>-2 palmitate on temperament development in term infants: potential role of gut <i>Bifidobacterium</i>.
   Qiu YZ, Yang MT, Liu Z, Chen XY, et al · · 2026 · PMID 41705972 · DOI 10.1039/d5fo03451e